"65FR78494" indicates a notice of some kind was published in the Federal Register
(FR) for a particular date. The FR can be found at http://www.fda.gov/ohrms/dockets/ and then go to the Federal Register section.
Interim Response is not a final decision on the petition.
| Date Filed |
Docket # |
Name of Petitioner/Subject
Matter |
Disposition |
| January |
| 01/04/2007 |
2007P-0003 |
Pharmaceutical Scientist Inc./Issue guidelines on Risk-Based
Bioequivalence Testing |
Pending |
| 01/05/2007 |
2007P-0004 |
Dean Andrew Kantis/Take steps to insure the safey of Americans
regarding th misues of Lasik |
Pending |
| 01/08/2007 |
2007P-0008 |
Vaccine for All LLC/Create a new policy to achieve expanded
and accelerated development and production of pre-pandemic and
pandemic vaccine |
Pending |
| 01/16/2007 |
2007P-0022 |
Lachman Consultant Services, Inc./ANDA Suitability Petition
for Oral Transmucosal Fentanyl Citrate |
Pending |
| 01/16/2007 |
2007P-0023 |
Victor L. Yu, M.D./Modify the in vitro breakpoints for penicillin
and Streptococcus pneumoniae originally set by Clinical and
Laboratory Standards Institute |
Pending |
| 01/17/2007 |
2007P-0028 |
Lachman Consultant Services, Inc/Determine whether Seroquel,
150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been
withdrawn for safety or effectiveness reasons |
Pending |
| 01/22/2007 |
2007P-0030 |
Lachman Consultant Services, Inc./ANDA Suitability for Acetaminophen
400 mg, Butalbital 50 mg and Caffeine 40 mg Capsules |
Pending |
| 01/23/2007 |
2007P-0033 |
Ellen M. Ashworth/Amend the Nutrition Facts label on food
products as it relates to trans fats. |
Pending |
| 01/23/2007 |
2007P-0034 |
JRRapoza Associates, Inc./To make a determination on three
(3) reference listed drug products that have not been withdrawn
from commercial distribution for reasons other than safety or
effectiveness |
Pending |
| 01/29/2007 |
2007P-0037 |
Lachman Consultant Services, Inc./Declare that Loratadine
Orally-Dissolving Strips, 5mg and 10mg, for an abbreviated new
drug application (ANDA) |
Pending |
| 01/30/2007 |
2007V-0039 |
Lasersmith Light Show Systems, LLC/Laser Light Show |
Pending |
| 01/31/2007 |
2007P-0042 |
Lachman Consultant Services, Inc./ANDA Suitability for Zolpidem
Tartrate Orally-Dissolving Strips |
Pending |
| Top |
| February |
| 02/01/2007 |
2007P-0043 |
Lachman Consultant Services, Inc. /ANDA Suitability for Ondansetron
Orally-Dissolving Strips |
Pending |
| 02/06/2007 |
2007P-0044 |
Public Citizen's Health Research Group/Ban Third Generation
Oral Contraceptives Containing Desogestrel Due to Increased
Risk of Venous Thrombosis |
Pending |
| 02/07/2007 |
2007P-0047 |
University of Florida/Amend the Dosage of Oral Phenylephrine
Listed in the Final Monogrph on Oral Decongestants |
Pending |
| 02/08/2007 |
2007V-0048 |
Baylor University/Laser Light Show |
Pending |
| 02/09/2007 |
2007P-0052 |
West-Ward Pharmaceutical Corp./determine whether a listed
drug(Brethine) that has been voluntarily shortened from distribution
and sale was shortened for reasons other than for safety or
effectiveness reasons |
Pending |
| 02/12/2007 |
2007V-0054 |
Daytona Beach Planetarium/Laser Light Show |
Pending |
| 02/12/2007 |
2007V-0056 |
Heritage Planetarium/Laser Light Show |
Pending |
| 02/20/2007 |
2007P-0059 |
Cancer Prevention Coalition et al/Withdrawal of New Animal
Drug Application for Posilac - Rombinant Bovine Growth Hormone
(rBGH) |
Pending |
| 02/20/2007 |
2007P-0060 |
West-Ward Pharmaceutical Corp./ANDA Suitability for Hydrocortisone
Tablets USP, 10 mg, (CORTEF) and Determine if CORTEF was Withdrawn
for Safety or Efficacy Reasons |
Pending |
| *02/21/2007 |
2007P-0062 |
Regulus Pharmaceutical Consulting, Inc./Determine Whether
a Previously Listed Drug Eloxatin (oxaliplatin for injection)
Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been
Voluntarily Withdrawn From Sale for Safety or Efficacy Rea |
Closed 11/26/2007 |
| 02/22/2007 |
2007V-0063 |
Sabeus, Inc./Variance for Alternate Means of Handling Interlocks
- Sabeus AG-1 Laser System |
Pending |
| 02/22/2007 |
2007P-0065 |
Pharmacists Planning Service, Inc./To increase print size
of direct-to-consumer advertisements |
Pending |
| 02/27/2007 |
2007V-0067 |
Aqua Night Club/Laser Light Show |
Pending |
| Top |
| March |
| 03/01/2007 |
2007P-0070 |
Charles E. Weber/Make fluoride a prescription drug for use
in tooth application, tooth paste, and in bottled water |
Interim Response 08/23/2007 |
| 03/01/2007 |
2007P-0071 |
Lachman Consultant Services, Inc./ANDA Suitability for Bisoprolol
Fumarate and Hydrochlorothiazide Tablets |
Pending |
| 03/01/2007 |
2007P-0072 |
Lachmman Consultant Services, Inc. /ANDA suitability for Metoprolol
Tartrate Tablets |
Pending |
| 03/01/2007 |
2007P-0074 |
Baltimore City Health Department et al/Take specific action
with respect to 21 CFR 341, the Final Monograph for Cough, Cold
Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter
Human Use |
Pending |
| 03/01/2007 |
2007V-0075 |
ARJAY-ELLIS LLC/Laser Light Show |
Pending |
| 03/01/2007 |
2007P-0076 |
Sovereign Pharmaceuticals, Ltd/ANDA Suitability for Promethazine
Hydrochloride and Hydrocodone Bitartrate Syrup, 6.25 mg/2.5
mg per 5 mL and 6.25 mg/1.67 mg per 5 mL |
Pending |
| 03/05/2007 |
2007P-0079 |
David K. Richardson/To sanction third party independent scientific
analysis of zine gluconate (ZICAM) additional safety standards
for the homeopathic industry |
Pending |
| 03/07/2007 |
2005H-0271 |
TMJ Implants, Inc., Robert W. Christensen, and Maureen Mooney/Civil
Money Penalty: TMJ Implants, Inc. |
Pending |
| 03/09/2007 |
2007V-0081 |
Fusion Laser Light Show/Laser Light Show |
Approved 03/27/2007 |
| 03/09/3007 |
2007V-0082 |
Information Database Solutions/Laser Light Show |
Approved 03/27/2007 |
| 03/12/2007 |
2007A-0087 |
WileyRein LLP/Request for an advisory opinion with respect
to the FDA's interpretation of 21CFR314.70(c)(6)(iii) regarding
NDAs to implement safety-related changes to prescription drug
labeling |
Pending |
| 03/12/2007 |
2007V-0088 |
Platinum Graphics/Projector for a Laser Light Show |
Pending |
| 03/13/2007 |
2007P-0093 |
Perdue Pharma L.P./Refuse to approve CIP-TRAMADOL ER until
Cipher complies with the investigations Reports to show the
safety and effectiveness of the drug |
Interim Response 09/07/2007 |
| 03/13/2007 |
2007V-0095 |
Number not used/Number not used |
Pending |
| 03/14/2007 |
2007P-0094 |
Greenberg Traurig LLP/Switch Allegra (Fexofendaine Hydrochloride),
and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine
Hydrochloride; Pseudophedrine Hydrochloride) from prescription
drugs to over-the-counter |
Interim Response 09/07/2007 |
| 03/14/2007 |
2007V-0102 |
Number not used/Number not used |
Pending |
| 03/14/2007 |
2002V-0347 |
Technological Artisans/Laser light show |
Approved 03/27/2007 |
| 03/15/2007 |
2007P-0096 |
Jennifer McGinn/Revoke 21 C.F.R. 165.110(a)(2)(vi), the rule
regulating the labeling of bottled water sources |
Pending |
| 03/15/2007 |
2007P-0097 |
Issue a new regulation wine product the composition of wine,
water, sugar, with or without flavorings and an alcohol content
of less than 75% can not be marketed or sold with a wine varietal
designation |
Pending |
| 03/15/2007 |
2007P-0100 |
JR Rapoza Associates, Inc./Abbreviated New Drug Application
(ANDA) filing of Ciprofloxacin Hydrochloride Capsules, 100 mg,
250 mg, and 750 mg |
Pending |
| 03/20/2007 |
2007P-0103 |
Keller And Heckman LLP/ANDA Suitability for Carvedilol Phosphate
Extended-Release Tablets |
Pending |
| 03/22/2007 |
2007P-0110 |
Pfizer Inc/To enforce pediatric exclusivity rights for amlodipine |
Denied 05/18/2007 |
| 03/22/2007 |
2007P-0111 |
Pfizer Inc./Stay approval of any and all supplements to Lotrel
concerning amlodipine and pediatric exclusivity |
Denied 05/18/2007 |
| 03/23/2007 |
2007P-0112 |
Three-Laboratory Consortium/Stay the implementation of recommendations
currently being provided by CDER staff to companies concerning
conduct of clinical trials and proposed statistical analyses
for the efficacy requirements of |
Pending |
| 03/26/2007 |
2006P-0113 |
B Braun Medical, Inc./ANDA Suitability for 15% Amino Acid
Injection Product |
Pending |
| 03/26/2007 |
2006P-0116 |
Mylan Pharmaceuticals Inc./Stay any additional Abbreviated
New Drug Applications for generic Amlodipine products until
after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires
on September 23, 2007 |
Pending |
| 03/27/2007 |
2007P-0119 |
Lachman Consulant Services, Inc. /ANDA Suitability for Hydrocodone
Bitartrate and Homatropine Methylbromide Syrup |
Pending |
| 03/27/2007 |
2007P-0134 |
Lachman Consulting Services Inc./ANDA Suitability for Hydrocodone
Bitrartrate and Homatropine Methylbroomide Tablets, 2.5 mg /
0.75 mg |
Pending |
| 03/29/2007 |
2007P-0124 |
Olsson, Frank And Weeda, P. C./ANDA Suitability for clindamycin
phosphate foam (non-aerosol), 1% |
Pending |
| 03/30/2007 |
2007P-0126 |
PFI LLC/Amend Existing Regulation for Strength from 4.0-90
mci/mL to 0.0-475 mci/mL Concerning NDA 20-306 (Fludeoxyglucose
F 18 Injection) |
Pending |
| Top |
| April |
| 04/02/2007 |
2007P-0127 |
Ortho-McNeil, Inc./Determine that any versions of tramadol
for once-daily dosing will not be approved prior to expiration
of three-year period of exclusivity for Ultram ER |
Pending |
| 04/03/2007 |
2007V-0128 |
Sunset Productions/Laser Light Show |
Pending |
| 04/03/2007 |
2007P-0129 |
C Smith/To revoke the food processing permit granted to Bella
Cucina Artful Food |
Pending |
| 04/04/2007 |
2007P-0130 |
Zydus Pharmaceuticals USA, Inc./Seeking Immediate Approval
of ANDA No. 78-226 for Amlodipine Besylate |
Withdrawn 09/28/2007 |
| 04/10/2007 |
1975N-0183F |
Century Pharmaceuticals, Inc. (CPI)/Topical Antimicrobial
Drug Products For OTC Human Use - First Aid |
Pending |
| 04/10/2007 |
2007P-0140 |
Warner Chilcott Inc./Stay final approval and/or effective
date of final approval of any 0.4. mg Norethindrone and 35 microgram
Ethinyl Estradiol oral chewable tablet product ANDAs unless
there is pharmaceutical e |
Interim Response 10/05/2007 |
| 04/10/2007 |
2007V-0141 |
Laser Design Productions/Laser Light Show |
Pending |
| 04/11/2007 |
1975N-0183H |
Century Pharmaceuticals, Inc./Health-Care Antiseptic Drug
Products for OTC Human Use |
Pending |
| 04/12/2007 |
1996V-0138 |
FDA/CDRH to Strictly FX LLC/Laser Light Show |
Pending |
| 04/12/2007 |
2007P-0142 |
Acorda Therapeutics, Inc./Incorporate the full proprietary
name Zanaflex Capsules, intead of the truncated form of the
name Zanaflex |
Interim Response 10/04/2007 |
| 04/13/2007 |
2007P-0147 |
Sara Lee Corporation/Use of the Term Natural Consistent with
USDA's Food Safety and Inspection Service |
Pending |
| 04/19/2007 |
2007P-0159 |
Alcon Research, Ltd./Take prompt enforecment actions due to
the clearly defined public health risk of Toxic Anterior Segment
Syndrome (TASS) and secure the removal of illegally marketed
unapproved ophthalmic Balanced Salt |
Pending |
| 04/20/2007 |
2007P-0157 |
Medicis/Request for Stay Granting Provisional Market Exclusivity
and Patent Listing for Ziana |
Pending |
| 04/20/2007 |
2007P-0158 |
Medicis/Patent Listing and Market Exclusivity for Combination
Drugs When One Component is a pre- 1997 Antibiotic Ingredient |
Pending |
| 04/23/2007 |
2007N-0120 |
Barnev Ltd./Medical Devices; Obstetrical and Gynecological
Devices; Classification of Computerized Labor Monitoring System |
Pending |
| 04/24/2007 |
2007A-0164 |
AFrame Digital, Inc/Request for Advisory Opinion for an Mobilecare
Monitor System 2100 |
Pending |
| 04/27/2007 |
2007P-0167 |
Akorn-Strides, LLC/Permit filing of an ANDA for Dexamethasone
Sodium Phosphate Injection USP, 10 mg/mL Injectioon, 10 mg/mL
-- 10 mL fill size |
Pending |
| 04/27/2007 |
2007V-0170 |
Moonlight Productions/Projector for a Laser Light Show |
Pending |
| 04/27/2007 |
2007P-0171 |
Mylan Laboratories, Inc./Not delist U.S. patent 4,879,303
(the 303 patent) for Norvasc amlodipine besylate product |
Pending |
| Top |
| May |
| 05/01/2007 |
2007P-0172 |
Aurobindo Pharmaceuticals Ltd./Determine whether Minocycline
Hydrocholoride, Minocin Capsules EQ 75 mg Base Manufactures
by Triax Pharmaceuticals, Ltd., has been valintarily withdrawn
from sale for safety or efficacynreasons. |
Pending |
| 05/01/2007 |
2007P-0178 |
Association of Medical Device Reprocessors/Take action to
subject certain cardiac surgery devices to premarket notification
(510(k) requirements |
Pending |
| *05/02/2007 |
2007P-0175 |
Norbrook, Inc./ANADA Suitability for ivermectin/pyrantel pamoate
chewable tablets |
Closed 11/27/2007 |
| 05/02/2007 |
2007P-0093 |
Purdue Pharma L.P./Refuse to approve CIP-TRAMADOL ER until
Cipher complies with the investigations Reports to show the
safety and effectiveness of the drug |
Pending |
| 05/02/2007 |
2007P-0127 |
Purdue Pharma L.P./Determine that any versions of tramadol
for once-daily dosing will not be approved prior to expiration
of three-year period of exclusivity for Ultram ER |
Pending |
| 05/03/2007 |
2007P-0177 |
Norbrook Laboratories Limited/ANADA Suitability for generic
new animal drug meloxicam which differs from the pioneer product,
Metacam 1.5 mg/mL Oral Suspension |
Pending |
| 05/04/2007 |
2007V-0181 |
Apollo Instruments, Inc./Interlock for Laser Modules and Beam
Attenuator |
Pending |
| 05/07/2007 |
2007P-0187 |
J Shingara/Requirements of Iodized Salt on Ingredient Labels |
Pending |
| 05/09/2007 |
2007N-0136 |
Agendia BV/Medical Devices; Immunology and Microbiology Devices;
Classification of Gene Expression Profiling Test System for
Breast Cancer Prognosis |
Pending |
| 05/11/2007 |
2007P-0194 |
Lachman Consultant Services, Inc./to permit the filingof an
abbreviated new drug application (ANDA) for Acetaminophen, Butalbital,
Caffeine and Hydrocodone Bitartrate Capsules |
Pending |
| 05/14/2007 |
2007V-0196 |
LaserMax/Laser Gunsight |
Pending |
| 05/15/2007 |
2007V-0199 |
Classic Sound machine/Laser Display Device |
Pending |
| 05/18/2007 |
2007P-0203 |
Orgenus Pharma, Inc./Abbreviated New Drug Application (ANDA)
Suitability for Memantine Hydrochloride Orally Disintegrating
Tablets 5 mg and 10 mg |
Pending |
| 05/21/2007 |
2007P-0205 |
Emil A. Tanghetti, M.D./Withdraw approval of and recall all
available stock of Ziana or require the immediate initiation
of long-term safety studies evaluating the incidence and prevalence
of antibiotic resistance associated |
Pending |
| 05/22/2007 |
2007P-0209 |
Sandoz Inc./Not to grant final ANDA approval for any generic
versions of Toprol-XL, metoprolol succinate extendend-release
tablets (metoprolol) 50 mg |
Pending |
| 05/22/2007 |
2007P-0210 |
HiFi DNA Tech, LLC/Reclassification Petition for Human Papillomavirus
(HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under
Section 513(f), 21 CFR 860 Subpart C |
Pending |
| 05/23/2007 |
2007P-0211 |
Sheppard Mullin Richter & Hampton LLP/Determine that the
listed drugs, oxycodone hydrochloride extended release tablets,
15 mg, 30 mg, and 60 mg, were voluntarily withdrawn by Purdue
Pharma LP, for reasonsother than safety |
Pending |
| 05/24/2007 |
2007P-0214 |
Sandoz, Inc./ANDA Suitability for Cefazolin Injection, USP
2 g Vials |
Pending |
| 05/25/2007 |
2003V-0179 |
Musititlan Entertainment/Laser Light Show |
Pending |
| 05/29/2007 |
1977N-0094 |
Brian Kaplan, M.D./OTC Internal Analgesic, Antipyretic &
Antirheumatic Products |
Pending |
| 05/30/2007 |
2007P-0216 |
Ben Venue Laboratories, Inc./Determine that an additional
dosage of Deferoxamine Mesylate for Injection, USP is suitable
for an abbreviated new drug application (ANDA) |
Pending |
| 05/30/2007 |
1978N-0038 |
Office of the Connecticut Attorney General/Sunscreen Drug
Products |
Pending |
| Top |
| June |
| 06/01/2007 |
2005V-0145 |
Disneyland Resort/Laser Light Show |
Pending |
| 06/07/2007 |
2007V-0222 |
Tempest International LLC/Projector for a Laser Light Show |
Approved 08/14/2007 |
| 06/07/2007 |
2007P-0224 |
Sanofi Aventis U.S. Inc./ANDA Suitability Petition for NDA
21-774 Ambien CR (Zolpidem tartrate) |
Pending |
| 06/07/2007 |
2004P-0006 |
Kleinfeld, Kaplan and Becker, LLP/Stay approval of abbreviated
new drug applications for controlled release oxycodone hydrochloride
products that list OxyContin oxycodone HCI controlled-release |
Closed 06/07/2007 |
| *06/07/2007 |
2007P-0232 |
Kleinfeld, Kaplan and Becker, LLP/Stay approval of abbreviated
new drug applications for controlled release oxycodone hydrochloride
products that list OxyContin oxycodone HCI controlled-release |
Interim Response 12/06/2007 |
| 06/08/2007 |
2007P-0226 |
Lachman Consultant Services, Inc./to permit an ANDA suitability
for Donepezil Hydrochloride Orally Dissolving Film Stripps,
5 mg and 10 mg |
Pending |
| 06/08/2007 |
2000D-0109 |
Clinical and Laboratory Standards Institute/Assessment of
Antimicrobial Susceptibility Devices |
Pending |
| *06/08/2007 |
2007P-0237 |
Clinical and Laboratory Standards Institute/Clear new susceptibility
test devices or modification of existing devices using Clinical
and Laboratory Standards Institute (CLSI) interpretive breakpoints
in those instances regarding susceptibility
|
Interim Response 12/06/2007 |
| 06/11/2007 |
2003V-0550 |
Whatergy, Inc./Laser Light Show |
Pending |
| 06/12/2007 |
2005V-0266 |
Stone Mountain Media/Laser Light Show |
Pending |
| *06/15/2007 |
2007P-0235 |
Compassion Over Killing & Peen Law Animal Law Project-University
of Pennsylvania Law School/Change the labeling requirements
for eggs sold in the United States
|
Interim Response 12/13/2007 |
| 06/19/2007 |
2007P-0239 |
Lachman Consultant Services, Inc./ANDA Suitability for Escitalopram
Oxalate Orally Dissolving Film Strips, 5 mg, 10 mg and 20 mg
|
Pending |
| 06/19/2007 |
2007V-0242 |
Prismatic Magic LLC/Variance for a projector for a laser light
show |
Pending |
| 06/19/2007 |
2007V-0243 |
Fyxx Enteraiment/Laser Light Show |
Pending |
| 06/20/2007 |
2007P-0247 |
Lachman Consultant Services, Inc./ANDA Suitability for Diflunisal
Tablets USP, 375 mg |
Pending |
| 06/21/2007 |
2007V-0248 |
Slick Productions/Laser Light Show Display |
Pending |
| 06/21/2007 |
2007FL-0236 |
The Solae Company/Food Allergen Labeling Petition (FALP):
Soy lecithin when used as processing aids
|
Pending |
| *06/22/2007 |
2007P-0250 |
HARMD (Helping America Reduce Methadone Deaths)/Enact stricter
guidelines in prescribing methadone for any reason
|
Interim Response 12/10/2007 |
| *06/22/2007 |
2007P-0251 |
Public Citizen Health Research Group/Petition for a policy
statement requiring that all future advisory committee meetings
discussing specific products include an oral scientific presentation
by FDA staff on the products reviewed, includ
|
Interim Response 12/10/2007 |
| *06/22/2007 |
2007A-0261 |
Ropes & Grays LLP/Advisory Opinion request to list certian
types of patents in the Orange Book |
Interim Response 12/17/2007 |
| 06/25/2007 |
2007V-0258 |
Neptec Design Group/Laser Camera System |
Pending |
| Top |
| July |
| 07/03/2007 |
2007P-0273 |
Clinical and Laboratory Standards Institute/Request that CDER
update the official drug labels for penicillin G potassium and
penicillin Gsodium for injection |
Pending |
| *07/03/2007 |
2007P-0274 |
FDA/DDM to Clinical and Laboratory Standards Institute/Request
that CDRH allow 510(k) clearance of devices for antimicrobial
susceptibility testing of Streptococcus pneumoniae with pencillin |
Interim Response 12/06/2007 |
| 07/09/2007 |
2006N-0362 |
Ferrosan A/S/General and Plastic Surgery Devices; Reclassification
of the Absorbable Hemostatic Device
|
Pending |
| 07/09/2007 |
2007V-0271 |
Margaret C. Woodson Planetarium/Laser Light Show |
Pending |
| 07/09/2007 |
2007P-0272 |
Lachman Consultant Services, Inc./ANDA Suitability for Acetaminophen,
Caffeine and Dihydrocodeine Tablets, 534.6 mg/45 mg/24 mg |
Pending |
| 07/10/2007 |
2007P-0275 |
Lachman Consultant Services, Inc/To permit an ANDA Suitability
for Nabumetone Tablets 1000 mg |
Pending |
| 07/13/2007 |
2007V-0281 |
P.A.W.N. LLC/Projector for a Laser Light Show |
Pending |
| 07/13/2007 |
2007P-0282 |
Dawn Densmore/Require all products labels to include this
information: Products % Costs Packaging: 80% Content: 20% |
Pending |
| 07/13/2007 |
2007P-0283 |
Purdue Pharma L.P./Take actions with respect to NDAs and ANDAs
seeking approval of modified release oral dosage form drug products
containing opioid active ingredients |
Pending |
| 07/16/2007 |
1999V-4395 |
Lightwave International, Inc/Laser Light Show |
Pending |
| 07/23/2007 |
2007P-0293 |
Emcure Pharmaceuticals USA, Inc. /To permit an ANDA Suitability
for Fenoprofen Calcium Capsules, 400 mg |
Pending |
| 07/24/2007 |
2007P-0295 |
Regulus Pharmaceutical Consulting, Inc./Make a determination
that Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20
mg, NDA 016418, Product Numbers 001 and 003 respectively) held
by Wyeth Pharmaceuticals, Inc., were not discontinued |
Pending |
| 07/24/2007 |
2006P-0123 |
Mylan Technologies Inc./Request that all applicants for fentanyl
transdermal systems conduct a study to support the safety of
their fentanyl transdermal products |
Pending |
| 07/25/2007 |
1996N-0417 |
American Herbal Products Association/CGMP in Mfg. Packing
or Holding Dietary Supplements |
Pending |
| 07/27/2007 |
2007P-0296 |
Mutual Pharmaceutical Co./Request that the FDA requires labeling
changes for Skelaxin (active ingredient metaxalone) as set forth
in the proposed revised packaging insert |
Pending |
| 07/30/2007 |
2007P-0297 |
CareToLive/Request to reconsider the failure to approve Provenge |
Pending |
| 07/30/2007 |
2007P-0302 |
Axcan Scandipharm, Inc./Require all manufacturers of a generic
verision of CANASA (mesalamine) rectal suppositories to perform
an adequate and well-controlled clinical safety and effectiveness
trial |
Pending |
| 07/31/2007 |
2007P-0300 |
B Braun Medical, Inc./ANDA Suitability for 15% Amino Acid
Injection product in a package size not covered under the Reference
Listed Druin a package size not covered under the Reference
Listed Drug's (RLD) application |
Pending |
| Top |
| August |
| *08/01/2007 |
2007P-0301 |
Immunotec, Inc./Alkaline and Earth Alkaline Citrates and Osteoporosis;
Health Claim Peition |
Denied 10/31/2007 |
| 08/03/2007 |
2007P-0307 |
Lachman Consultant Services, Inc./ANDA Suitability for Hydrocodone
Bitartrate and Homatropine Methylbromide Capsules 5 mg / 1.5
mg |
Pending |
| 08/08/2007 |
2007V-0312 |
Catawba Science Center/Laser Display Device |
Pending |
| 08/08/2007 |
2007V-0314 |
Williamsville Space Lab Planetium/Laser Light Show |
Pending |
| 08/08/2007 |
2007V-0315 |
Hollywood Pro Lighting/Projector for a Laser Light Show |
Pending |
| 08/08/2007 |
2007P-0316 |
Teva Pharmaceuticals USA/Risperdal (Risperidone) Tablets |
Pending |
| 08/10/2007 |
2007P-0318 |
Cornerstone Regulatory/Declare that, Glucagon Hydrochloride
(Glucagon) for Injection is suitable for an abbreviated new
drug application (ANDA) |
Pending |
| 08/13/2007 |
2007V-0319 |
Geller/Laser Light Show |
Pending |
| 08/14/2007 |
2007P-0210 |
HiFi DNA Tech, LLC/Reclassification Petition for Human Papillomavirus
(HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under
Section 513(f), 21 CFR 860 Subpart C |
Pending |
| 08/14/2007 |
2007P-0320 |
Health Care Without Harm/Regulation or Guideline to Label
Medical Devices that Leach DEHP Plasticizers |
Pending |
| 08/14/2007 |
2007P-0322 |
Takeda Pharmaceuticals North America/Approval of Generic Versions
of Pioglitazone Hydrochloride with Less than Complete Labeling |
Pending |
| 08/20/2007 |
2007P-0326 |
AAIPharma, Inc. /Determine Whether Sanorex (Mazindol) Tablets,
1 and 2 mg, (NDA 17-247), by Novartis, Have Been Voluntarily
Withdrawn or Withheld From Sale for Safety or Efficacyr Reasons |
Pending |
| 08/24/2007 |
2007P-0331 |
Coalition for Mercury-Free Drugs/Ban Use of Mercury In Medicine,UNLESS
Proven Toxicologically Safe to the CGMP Standard Sufficiently
Nontoxic |
Pending |
| 08/24/2007 |
2007A-0332 |
Alston & Bird LLP/Advisory Opinion request for Mandatory
Black Box warnings on all Bovine Thrombin Products |
Pending |
| 08/28/2007 |
2007P-0334 |
Anil K. Mandal, M.D./Prohibit the use of low molecular weight
heparin in patients with acute or chronic renal failure and
in elderly subjects more than 65 years of age |
Pending |
| 08/28/2007 |
2007V-0335 |
Dodd Technologies, Inc./Projector for a Laser Light Show |
Pending |
| Top |
| September |
| 09/04/2007 |
2007P-0346 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
possible refusal of AQZ-0250569-4 and AQZ-0250573-6 as a consequence
of the denial by Los Angeles District of the FD-766 |
Pending |
| 09/04/2007 |
2007P-0333 |
Dave Wayne/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa |
Pending |
| 09/05/2007 |
2007P-0336 |
Matrix Laboratories, Inc./To permit an ANDA Suitability for
RitonavirTablets, 100 mg |
Pending |
| 09/05/2007 |
2007P-0333 |
Dwight G. Castle/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa |
Pending |
| 09/05/2007 |
2007P-0345 |
International Pacific LLC d.b.a. Pacific Supreme/Stay the
effective date of any possible refusal of Entry AQZ-0250069-5
as consequence of the denial by Los Angeles District of the
FD-766 |
Pending |
| 09/07/2007 |
2007V-0338 |
Palomar Medical Technologies, Inc./Variance for an Alternate
Beam Attenuator |
Pending |
| 09/12/2007 |
2007V-0349 |
Amanda Kushner/Laser Light Show |
Pending |
| 09/13/2007 |
2007V-0339 |
Top Shelf Club/Laser Light Show |
Pending |
| 09/13/2007 |
2007V-0340 |
Eastside Entertainment LLC/Laser Light Show |
Pending |
| 09/13/2007 |
2007P-0341 |
Sun Pharmaceuticals, Ltd./Determine whether Zometa (Zoledronic
Acid for Injection) has been Withdrawn for Safety or Effectiveness
Reasons |
Pending |
| 09/13/2007 |
2007P-0333 |
John Gilbert/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa |
Pending |
| 09/17/2007 |
2007P-0333 |
Michael E. Masterman/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa |
Pending |
| 09/17/2007 |
2007P-0333 |
John W. Shaw/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa |
Pending |
| 09/18/2007 |
2007V-0350 |
Vestar Temple Market Place/Laser Light Show Display |
Pending |
| 09/18/2007 |
2007P-0333 |
Rebecca Gilbert/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa |
Pending |
| 09/18/2007 |
2007P-0351 |
Engal & Novitt, LLP/Address the potential drug-safety-and
efficacy-related issues that are expected to arise in connection
with the issuance of final approvals for at least seven (7)
tentatively-approved applications see |
Pending |
| 09/18/2007 |
2007P-0351 |
Engel & Novitt, LLP/Address the potential drug-safety-and
efficacy-related issues that are expected to arise in connection
with the issuance of final approvals for at least seven (7)
tentatively-approved applications see |
Pending |
| 09/19/2007 |
2007P-0369 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251860-6 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extensio |
Pending |
| 09/19/2007 |
2007P-0370 |
Thunder Bay Seafood Co., Inc/Stay the effective date of any
refusal of Entry AQZ-0251196-5 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extension of time to supply the |
Pending |
| 09/19/2007 |
2007P-0371 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251197-3 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extension of time to supply the re |
Pending |
| 09/19/2007 |
2007P-0372 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251198-1 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extension of time to supply the re |
Pending |
| 09/19/2007 |
2007P-0373 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251199-9 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extension of time to supply the re |
Pending |
| 09/19/2007 |
2007P-0374 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251206-2 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extension of time to supply the re |
Pending |
| 09/19/2007 |
2007P-0375 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251212-0 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extension of time to supply the re |
Pending |
| 09/19/2007 |
2007P-0376 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251619-6 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extension of time to supply the re |
Pending |
| 09/19/2007 |
2007P-0377 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251620-4 as a |
Pending |
| 09/19/2007 |
2007P-0378 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0251861-4 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 7 day extension of time to supply the re |
Pending |
| 09/20/2007 |
2007P-0352 |
HellerEhrman LLP/FDA withdrawn the commercial marketing authorization
for oral sodium phosphate (OSP) products for bowel cleansing
and reclassify all OSP products for bowel cleansing as prescription
only medicines |
Pending |
| 09/21/2007 |
2007P-0354 |
Celgene Corporation/Refrain from approving Any Application
for a Generic Thalidomide Product |
Pending |
| 09/24/2007 |
2007P-0358 |
Astellas Pharma U. S., Inc./Ensure the Safe and Effective
Use of Orally Administered Immunosuppressant Drugs That are
Used in the Transplant Population and are Characterized by a
Narrow Therapeutic Index
|
Pending |
| 09/25/2007 |
2007V-0360 |
Bel Entertainment LLC/Laser Light Show |
Pending |
| 09/26/2007 |
2007P-0361 |
King Pharmaceuticals, Inc./Approve Abbreviated New Drug Applications
(ANDA's) and 505 (b)(2) applications that reference drug products
containing auto-injectors-- and to make therapeutic equivalence
designations----only in acco |
Pending |
| 09/27/2007 |
2007P-0333 |
Lachman Consultant Services, Inc./To determine whetherNamenda
Tablets 15 mg and 20 mg (approved under NDA 21-487 owned by
Forest Laboratories) were Voluntarily withdrawn from sale for
reasons related to safety efficacy |
Pending |
| 09/27/2007 |
2007P-0362 |
Lachman Consultant Services, Inc./To determine whetherNamenda
Tablets 15 mg and 20 mg (approved under NDA 21-487 owned by
Forest Laboratories) were Voluntarily withdrawn from sale for
reasons related to safety efficacy |
Pending |
| 09/28/2007 |
2007P-0363 |
Unimed Pharmaceuticals, Inc./Prevent false and misleading
labeling and ensure the safe and effacious use of dronibinol |
Pending |
| 09/28/2007 |
2007P-0379 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
refusal of Entry AQZ-0252410-9 as a consequence of the denial
by Los Angeles District to provide Thunder Bay Seafood Co.,
Inc. a 30-day extension of time to supply the r |
Pending |
| Top |
| October |
| 10/03/2007 |
2007V-0383 |
Net Tek/Laser Light Show Device |
Pending |
| 10/03/2007 |
2007V-0384 |
Number not Used/Number not used |
Pending |
| 10/03/2007 |
2007P-0385 |
Ralph D. Childs/Electronic Product Radiation Control for Medical
Devices |
Pending |
| 10/05/2007 |
1981N-0033 |
Beutlich Pharmaceuticals LP/Oral Health Care Drug Products
for OTC Human Use |
Pending |
| 10/11/2007 |
2007P-0333 |
Michael F. Clark/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa
|
Pending |
| 10/15/2007 |
2007P-0399 |
Purdue Pharma L.P. and Rhodes Technologies/Adopt, announce,
and implement a consistent, CDER- wide standard for the acceptable
level of 14-hydroxycodeinone impurity in oxycodone HCI API approved
by FDA for use in drug products |
Pending |
| 10/15/2007 |
2007P-0399 |
Purdue Pharma L.P. and Rhodes Technologies /Adopt, announce,
and implement a consistent, CDER-wide standard for the acceptable
level of 14-hydroxycodeinone impurity in oxycodone HCI API approved
by FDA for use in drug products |
Pending |
| 10/16/2007 |
2007V-0397 |
Chevy Chase Productions/Laser Light Show |
Pending |
| 10/16/2007 |
2007P-0398 |
Lachman Consultant Services, Inc./ANDA Suitability for Zaleplon
Capsules, 7.5 mg |
Pending |
| 10/16/2007 |
2007P-0400 |
Richard Sauerheber, Ph.D./Formally ban unnaturally synthesized
fluoride compounds sold for consumption through oral ingestion |
Pending |
| 10/17/2007 |
2007P-0402 |
Fuerst, Humphrey, Ittleman, PL/Take regulatory enforcement
action to protect consumers from |
Pending |
| 10/18/2007 |
2007P-0403 |
VCU School of Medicine /ANDA Suitability for Levomethadyl
Acetate HCI 10mg 20mg and 40mg Tablets |
Pending |
| 10/18/2007 |
2007P-0333 |
Robert E. Parks/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa |
Pending |
| 10/19/2007 |
2007P-0404 |
Lupin Pharmaceuticals, Inc./Declare that Cefixime for Oral
Suspension, 100 mg/mL, is suitable for submission as an ANDA |
Pending |
| 10/22/2007 |
2007P-0405 |
Thunder Bay Seafood Company/Stay the effective date of any
possible refusal of entry AQZ- 0251621-2 |
Pending |
| *10/22/2007 |
2007P-0406 |
Thunder Bay Seafood Company/Stay the effective date any possible
refusal of entry AQZ-0251860-6 |
Pending |
| *10/22/2007 |
2007P-0435 |
Thunder Bay Seafood Company/Stay the effective date of any
possible refusal of entry AQZ- 0251619-6 |
Pending |
| *10/22/2007 |
2007P-0436 |
Thunder Bay Seafood Company/Stay the effective date of any
possible refusal of entry 595-4331551-5 |
Pending |
| 10/23/2007 |
2007P-0407 |
Matrix Laboratories, Inc./To permit the filling of a Abbreiated
new drug application (ANDA) for Abacavir Sulfate Tablets 60
mg |
Pending |
| 10/24/2007 |
2007P-0414 |
Cobalt Laboratories Inc., and Cobalt Pharmaceuticals Inc.,/Stay
approval of any and all subsequent abbreviated new drug applications
(ANDAs) for Acarbose Tablets 25mg, 50 mg, and 100 mg |
Pending |
| *10/25/2007 |
2007P-0421 |
Thunder Bay Seafood Co., Inc./Stay the effective date of any
possible refusal of entry AQZ-0251620-4 |
Pending |
| *10/26/2007 |
2007P-0420 |
The Alliance Against Alveolar Soft Part Sarcoma and The Sarcoma
Foundation of America/Issue a guidance document for the accelerated
approval of drugs and biologics that are intended to treat rare
cancers, including alveolar soft part sarcom |
Pending |
| *10/29/2007 |
2007P-0416 |
Prolacta Bioscience/To promulgate regulations defining human
milk to be a food, and for the conditation of neonatal prematurity,
a medical food |
Pending |
| *10/29/2007 |
2007P-0418 |
Solvay Pharmaceuticals, Inc./Prevention of False and Misleading
Labeling and Promotion of Safe and Efficacious Use of Dronabinol
|
Pending |
| *10/30/2007 |
2007P-0428 |
King and Spalding LLP/Abbreviated New Drug Application (ANDA)
suitable for diclofenac sodium and misoprostol, in respective
combinations of 50 mg/200 mcg and 75 mg/200 mcg |
Pending |
| *10/30/2007 |
2007P-0455 |
Sidelines National Support Network/Revoke the Orphan Drug
designation for Gestiva |
Pending |
| *10/31/2007 |
2007P-0429 |
The National Center on Addiction and Substance Abuse at Columbia
University/Take action to strengthen FDA regulation of controlled
prescription drugs, and help minimize the risks of diversion
of controlled prescription drugs, by issuing new rules |
Pending |
| *10/31/2007 |
2007P-0434 |
King Pharmaceuticals, Inc/To take the actions refrain from
approving a recombinant thrombin biologies license application
BLA |
Pending |
| Top |
| November |
| *11/01/2007 |
2007P-0431 |
Epidemiology and Community Health vcu School of Medicine/Determine
whether levomethadyl acetate HCI (Orlaam) NDA-20-315 has been
voluntarily withdrawn from sale for safety or efficacy reasons.
|
Pending |
| *11/02/2007 |
2007P-0438 |
National Toxic Encephalopathy Foundation/Declare Angel Parfum,
Angel Eau du Toilette and other Angel related fragranced products
be declared misbranded and have their importation ceased until
their safety can be independently verified |
Pending |
| *11/05/2007 |
2007P-0437 |
Matrix Laboratories, Inc. /To permit the filling of abberviated
new drug applicacation (ANDA for Lopinavir/ritonavirtablets
100 mg/ 25 mg |
Pending |
| *11/05/2007 |
2007P-0283 |
Endo Pharmaceuticals/Take actions with respect to NDAs and
ANDAs seeking approval of modified release oral dosage form
drug products containing opioid active ingredients |
Pending |
| *11/06/2007 |
2007V-0441 |
Night Vision System - A DRS Technologies Company/GCP-2C (V-2)
Variance Application for Night Vision System |
Pending |
| *11/09/2007 |
2007P-0333 |
Shawn Bryant/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all information for installa |
Pending |
| *11/09/2007 |
2007P-0333 |
James Whalen/Strict and immediate enforcement of performance
standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21
CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply
all |
Pending |
| *11/09/2007 |
2007P-0448 |
Cobalt Laboratories, Inc. and Cobalt Pharmaceuticals, Inc./Petition
Regarding Precose (Acarbose) |
Pending |
| *11/09/2007 |
2007P-0448 |
Cobalt Laboratories Inc. and Cobalt Pharmaceuticlas Inc/Petition
Regarding Precose (Acarbose) |
Pending |
| *11/13/2007 |
2007N-0382 |
Apotex, Inc./Ramipril Capsules and 180-day generic drug exclusivity |
Pending |
| *11/13/2007 |
2007V-0451 |
Mountain Megabytes Inc./Laser Light Show |
Pending |
| *11/13/2007 |
2007P-0450 |
Ebewe Parenta Pharmaceuticals, Inc./Determine whether a 200
mg/ vial presentation of Oxaliplatin for Injection (lyophilized
powder for infusion) may be file as an Abbreviated New Drug
Application Suitability |
Pending |
| *11/16/2007 |
2007P-0456 |
Sapna Lohiya/Amend exiting regulations 21 CFR, Part 202.1
(e)(1) |
Pending |
| *11/26/2007 |
2007P-0457 |
Mandatory Alternatives Petition Coalition/Mandatory Use of
Non-Animal Methods in the Development and Approval of Drugs
and Devices |
Pending |
| *11/30/2007 |
2007P-0465 |
United Research Laboratories, Inc. Mutual Pharmaceutical Company,
Inc./Review Labeling and Bioequivalence Standards for Felodipine
Extended-Release Tablets to Incorporate Safety Information and
Ensure Equivalent Product Safety and Effectiveness |
Pending |
| *11/30/2007 |
2007P-0466 |
Medicure Pharma/Prohibit the marketing of dietary supplements
containing Pyridoxal 5'-Phosphate |
Pending |
| Top |
| December |
| *12/04/2007 |
2007P-0470 |
Terence J. Mix, Esq./Administrative action regarding CLOMID
(clomiphene citrate), NDA 16-131 and its generics |
Pending |
| *12/06/2007 |
2007P-0473 |
W. L. Driscoll/To seek the creation of a new Food and Drug
Administration policy to achieve expanded anh accelerated development
and production of pre-pandemic and pandemic vaccine |
Pending |
| *12/10/2007 |
2007P-0475 |
Alston & Bird LLP/Take the following action with respect
to the scheduling and conduct of inspections associated with
drugs manufactured or processed at domestic and foreign facilities |
Pending |
| *12/12/2007 |
2007V-0476 |
X- Laser, L. L. C. / Laser Display Device |
Pending |
| *12/12/2007 |
2007V-0477 |
X- Laser L. L. C./Laser Light Show |
Pending |
| *12/12/2007 |
2007V-0048 |
Baylor University/Laser Light Show |
Pending |
| *12/12/2007 |
2007P-0483 |
Judy Slome Cohain/Restore FDA approval to Tecsana Epi-no birth
trainer and to remove the adverse event report on Tecsana Epi-No
from FDA website |
Pending |
| *12/17/2007 |
2007P-0479 |
Consumers Union/Require that all print and electronic advertisements,
including Internet advertisements, for implantable devices such
as knee, hip, heart valves, cosmetic implants, and other devices |
Pending |
| *12/18/2007 |
2007P-0482 |
Physicians Committee for Responsible Medicine (PCRM)/Change
the labeling for Avandia and other drugs in the thiazolidinedione
class to include information that a low-fat vegan diet has an
efficacy that is comparable to that of oral medications at managi
|
Pending |
| *12/20/2007 |
2007P-0486 |
Michael J. Dochniak/Issue a regulation for Hevea Basiliensis
natural-rubber-latex, used in the manufacture of infant products |
Pending |
| *12/20/2007 |
2007V-0490 |
KRP Music Work/Laser Light Show |
Pending |
| *12/21/2007 |
2007P-0488 |
Mutual Pharmaceutical Company, Inc./Ensure that newly discovered
CYP450 system phenotyping (metabolism) and inhibition information
is appropriately incorporated into labeling for Felodipine Extended-Release
Tablets USP (and other felodi |
Pending |
| *12/21/2007 |
2007N-0353 |
GRAS/E Coalition/Drug Products Containing Hydrocodone; Enforcement
Action Dates |
Pending |
| *12/27/2007 |
2007P-0499 |
Beckloff Associates, Inc./Determine whether a food-effect
study should be required as part of the demonstration of bioequivalence
for clozapine orally disintegrating tablets (ODT), 100 mg |
Pending |
| *12/28/2007 |
2007P-0500 |
John Edward Erb/Revoke the GRAS standing of the food additive
Monosodium Glutamate |
Pending |
